Position Overview
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Senior Regulatory Affairs Associate (Biologics/Small Molecules)
Around 4-6 years of relevant experience in handling life cycle management of approved drug products (small molecules as well as biologicals including Vaccines, monoclonal antibodies) in various markets.Good understanding of regulatory framework, including regional trends, for various types of applications and proceduresContribute to preparation (including authoring where relevant) and delivery of simple, and with experience, increasingly more complex regulatory maintenance submissions from either a global and/or regional perspective.Working knowledge of EU/US regulatory procedures including post approval requirements. Knowledge of ROW markets regulatory legislations would be an added advantageExperience in handling CMC related health authority queries, and author responses to HA reque...